CymaBay Therapeutics Presents Positive Phase 2 Data for Seladelpar

CymaBay Therapeutics (NASDAQ:CBAY) has announced positive results from its Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC).

As quoted in the press release:

These data are being presented today at The International Liver Congress™ 2019 of the European Association for the Study of Liver (EASL) in Vienna, Austria, along with three other seladelpar clinical and preclinical presentations. Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in development for PBC and nonalcoholic steatohepatitis (NASH).

In an oral presentation titled “Seladelpar for the treatment of primary biliary cholangitis: Experience with 25 cirrhotic patients,” Marilyn J Mayo MD, Associate Professor at the University of Texas, Southwestern Medical Center in Dallas, will be reporting the results of a subset of patients with compensated cirrhosis (Child-Pugh A) from an ongoing Phase 2 study designed to assess the safety and efficacy of seladelpar at a daily dose of 5 mg or 10 mg in PBC patients who had an inadequate response (alkaline phosphatase [AP] ≥ 1.67 x upper limit of normal [ULN]) or an intolerance to ursodiol and a total bilirubin ≤ 2 mg/dL. Cirrhosis was diagnosed using liver biopsy, liver elastography, or liver imaging. Patients initiated on 5 mg could be dose-escalated to 10 mg after 12 weeks of treatment if it was tolerated and AP threshold criterion was not met (5/10 mg group). The primary outcome was percent change from baseline in AP. Secondary outcome measures included ALT, total bilirubin, and pruritus using the visual analogue scale (VAS). At 52 weeks in patients with cirrhosis, mean relative decreases in AP were -36% and -43% in the 5/10 mg and 10 mg group, respectively. Treatment with seladelpar also demonstrated robust anti-inflammatory activity with a decrease in ALT comparable to what was observed in non-cirrhotic patients. Total bilirubin remained stable throughout 52 weeks. Seladelpar was well tolerated and appeared safe. Three patients with cirrhosis experienced an SAE, all unrelated to seladelpar. Total bilirubin, platelets, albumin, and INR remained stable. No liver decompensation events were observed. There was no transaminase safety signal, and importantly, seladelpar treatment was not associated with drug-induced pruritus or hepatotoxicity.

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